Sterilization Services Market Size, Share & Trends

The global sterilization services market is projected to reach USD 5.2 billion by 2029 from USD 3.6 billion in 2024, at a CAGR of 7.7% during the forecast period. The key factor driving market growth in the sterilization services market is outsourcing sterilization services to third-party vendors. Several hospitals, manufacturing companies, medical device manufacturers, and pharmaceutical companies outsource respective sterilization processes to reduce overall healthcare costs. Additionally, the cost benefits and enhanced sterilization services offered by third-party providers support market growth. The high growth potential of emerging economies is also expected to provide impetus to market players during the forecast period.

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Attractive Opportunities in Sterilization Services Market

Market Dynamics

DRIVER: Growing prevalence of hospital-acquired infections (HAIs)

Hospital-acquired infections (HAIs) are nosocomial infections that occur during a patient’s stay in hospitals and other related facilities; these are not observed during the patient’s initial admission. In recent years, HAIs have become a critical cause of concern for morbidity and mortality worldwide. These infections include central line-associated bloodstream infections, surgical-site infections, catheter-associated urinary tract infections, hospital-acquired pneumonia, ventilator-associated pneumonia, and Clostridium difficile infections. A critical factor associated with HAIs includes E. coli, the most common pathogen. E.coli can release toxins that damage the intestines and cause abdominal pain and diarrhea. Using infected medical devices during diagnostic & therapeutic procedures is also an additional factor causing HAIs.

Restraint: Concerns associated with safety of reprocessed instruments

There are concerns about the quality of sterilization & safety of reprocessed devices in the healthcare sector, during which medical devices are reprocessed to save money and reduce waste. The risk of surgical-site infections (SSIs) in patients can increase exponentially due to inadequate sterilization methods of medical devices, retaining blood, tissue, and other biological debris. Inadequate sterilization of these medical devices can cause tissue irritation from chemical disinfectants to the patient. These factors are expected to limit the acceptance of reprocessing among hospital administrators and physicians, thus restraining the market adoption to a certain extent. Few medical devices have complex characteristics; therefore, they are challenging to clean and reprocess. High temperature and pressure exerted on such devices during sterilization can cause them to degenerate. In recent years, the use of such devices has increased in the healthcare field, and proper sterilization is required to control infection outbreaks through these devices. Clinics and healthcare settings are inclined to utilize single-use instruments to provide quality treatment and reduce reprocessing errors to eliminate pathogens.

Opportunity: Potential of E-beam sterilization

Due to the growing applications of E-beam and its increasing uptake among end-user segments, the market for E-beam sterilization is expected to witness significant growth during the forecast period. E-beam sterilization offers several advantages over other methods of sterilization. Electron-beam irradiation is primarily used to sterilize medical devices and pharmaceutical packaging. Using E-beam, products can be irradiated for only a few seconds and may not be subject to radiation incompatibility, sometimes seen with gamma irradiation and ethylene oxide (EtO) sterilization. Moreover, the overall process time (including transportation time) averages five to seven minutes for e-beam sterilization. Products can be released from quarantine as sterile within 30 minutes using established & recognized dosimetry release procedures. E-beam takes the least time for sterilization processing; gamma irradiation and ethylene oxide sterilization take six hours and fourteen days; and the E-beam requires sixty seconds per package.

Challenges: Sterilization of advanced medical instruments

Specific concerns are related to sterilizing advanced medical devices, disinfection, and cleaning. Inadequate sterilization of these devices might expose patients to the risk of acquiring HAIs. Different medical devices require different methods of sterilization services. Due to the introduction of complex medical devices in the healthcare system, there is a need for an advanced sterilization process compatible with automated endoscope reprocessors. If these complex medical devices are not thoroughly sterilized, there can be an outbreak of microorganisms causing the multi-drug resistance pathogens to affect the patient’s health. Some countries have set stringent rules for the cleaning of such medical devices. Several organizations, such as the US FDA and others, have set out programs and regulations to ensure the adequate implementation of sterilization of medical devices.

Ecosystem Analysis

An ecosystem analysis is conducted to understand the elements of the sterilization services market. The ecosystem's elements comprise the services needed, technologies used, applications, and the prominence of end users. It is segmented into four broad divisions (category, method, type, and end user), which are further segmented into core technologies. The end users mentioned in this analysis are the key stakeholders in the supply chain of the sterilization services market.

“By method, gamma sterilization segment is projected to register the highest CAGR during the forecast period.”

Based on method, the global sterilization services market is segmented into ethylene oxide sterilization, gamma sterilization, e-beam sterilization, x-ray sterilization, steam sterilization, hydrogen peroxide sterilization, and other sterilization methods. Gamma sterilization has several advantages over other methods, such as better penetration, better certainty of sterility, and effectiveness independent of temperature, humidity, and pressure conditions. Gamma sterilization is considered valuable as it has a fast processing time for bulk items for sterilizing and has minimal residuals for packaging materials. These advantages assure continuous demand for this segment. Medical products using gamma sterilization include hypodermic needles and syringes, instruments, swabs, and scalpel blades. As gamma sterilization is conducted after the devices are packed in the final stage, the efficiency of the sterilization remains high until the packaging is tampered with. The growth of gamma sterilization will depend upon the availability of the cobalt-60 element.

“By end user, medical device companies segment accounted for largest market share in 2023”.

The sterilization services market is segmented into medical device companies, hospitals & clinics, pharmaceutical & biotechnology companies, and other end users. The medical device companies segment accounted for the largest market share in 2023; this segment is also expected to grow at the highest CAGR during the forecast period. Sterilizing devices is highly emphasized for this end-user segment to avoid nosocomial infections. The high efficiency of the sterilization process will reduce the nosocomial infections. The surgical instruments are mainly sterilized using low temperatures and heat. Still, the heat-sensitive instrument uses chemical methods or low temperature sterilization such as hydrogen peroxide gas plasma. Ethylene oxide sterilization is a dominant method used in medical device companies as it is highly effective and efficient. However, due to new regulations, the use of this method might start declining.

“Asia Pacific region to grow at highest CAGR during forecast period.”

The global sterilization services market is segmented into six regions: North America, Europe, the Asia Pacific, the Middle East & Africa, Latin America, and GCC Countries. The Asia Pacific region is expected to register the highest growth rate during the forecast period. The factors affecting the growth of sterilization services in this region are the rising nosocomial infections in poorly maintained hospitals and the increasing growth in medical device & pharmaceutical industries. The rising geriatric population and increasing incidence of chronic & infectious diseases are also expected to drive the uptake of sterile services. There is a growing need for customized sterilization services in the Asia Pacific region to provide countries with unique needs to facilitate medical & pharmaceutical standards.

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Key Market Players

The key players in this market are STERIS plc (Ireland), Sotera Health (US),  Servizi Italia S.p.A (Italy), E-BEAM Services, Inc. (US), BGS Beta-Gamma-Service GmbH & co. KG (Germany), Medistri SA (Switzerland), H.W.Andersen Products Ltd. (UK), Cretex Companies (US), Life Science Outsourcing, Inc. (US), Microtrol Sterilisation Services Pvt Ltd. (India), Avantti Medi Clear (Mexico), SteriPack Group (Ireland), Europlaz (UK), Prince Sterilization Services, LLC (US), Steripure (France), and SteriTek Inc. (US). The market leadership of these companies can be attributed to comprehensive product portfolios and expansive global footprint. These dominant market players have several advantages, including strong research & development budgets, strong marketing & distribution networks, and established brand recognition.

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Scope of the Report

This research report categorizes the sterilization servicesmarket into the following segments and subsegments:

Regional Split

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa
• GCC Countries

Sterilization services market, by method

• Ethylene oxide sterilization
• Gamma sterilization
• E-beam sterilization
• X-ray sterilization
• Steam sterilization
• Hydrogen peroxide sterilization
• Other methods

Sterilization services market, by type

• Contract sterilization services
• Sterilization validation services

Sterilization servicesmarket, by mode of delivery

• Off-site sterilization
• On-site sterilization

Sterilization servicesmarket, by end user

• Medical device companies
• Hospitals & clinics
• Pharmaceutical & biotechnology companies
• Other end users

Recent Developments

• In June 2024, STERIS plc (Ireland) expanded its existing gamma processing services in Canada, offering a comprehensive suite of sterilization solutions to meet diverse industry needs.
• In July 2024, STERIS plc (Ireland) opened a new ethylene oxide facility in Singapore to support medical device manufacturing.
• In June 2024, the merger of Servizi Italia S.p.A (Italy) and Ekolav S.r.l (Italy) was undertaken to enhance production synergies and contain general structural costs.
• In August 2023, STERIS plc (Ireland) announced the completion of the acquisition from BD’s surgical instrumentation assets (US) to expand its presence in the operating room and sterile processing department.
• In March 2023, Servizi Italia S.p.A (Italy) opened its first sterilization plant in São Paulo, Brazil.

Frequently Asked Questions (FAQ):

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